8 And So In the Rush to Enroll…Subject disqualification criteria may be overlookedSubjects may not be given full disclosure regarding trial objectivesSubjects may not be given full disclosure regarding associated risksSubjects may be rushed to participate (without given time to think it over)

9 FDA does not have authority to review financial agreementsInvestigator Management FDA’s ToolboxInvestigator Agreement – Form 1572Financial Disclosure by Clinical InvestigatorsFDA Bioresearch Monitoring Program – Clinical Sites, Sponsors, IRBsApplication of sanctions in association with violative behaviorsBUT -FDA does not have authority to review financial agreementsPoints to make:

11 Disregard to terms of agreement may be considered a criminal offenseInvestigator Management Investigator Agreement – FDA Form 1572Commits to conduct study in accordance with protocol, FDA regulations & IRB conditionsCommits to ensure informed consent requirements are met for all subjects (including controls)Commits to ensure that IRB reviews & approves study initially & on a continuing basisDisregard to terms of agreement may be considered a criminal offensePoints to make:

12 Investigator Management FDA Investigator Financial DisclosureApplies to FDA-directed marketing applications onlyNo financial arrangements where study outcome may affect investigator compensationInvestigator has no proprietary interest in tested productInvestigator has no significant equity interest in companyInvestigator has not received significant payments of other sortsPoints to make:

20 21 CFR 50.25 Consent Document Must IncludeStudy involves “research”; explains research purposeKnown risks/benefitsAlternative treatments or proceduresExtent to which confidentiality will be maintainedCompensation & medical tx available in event of injury or illnessContact(s) to discuss study/subject rightsParticipation is voluntaryPoints to make:

21 21 CFR 50.25 Add’l Consent Document LanguageTx may involve unforeseeable risksAnticipated circumstances when participation may be terminated w/o regard to consentAdditional costs to subject for participationConsequences associated with withdrawal of consentCommitment to provide info on significant new findings during study that may affect willingness to participateApproximate # of subjects involvedPoints to make:

23 Subject Recruitment Programs Print Recruitment Advertising Should IncludeName & address of investigator or research facilityCondition under study or purpose of researchSummary of criteria used to determine study eligibilityBrief list of participation benefits (including cash)Time or other commitment required of participantsLocation of research & who to contact for further informationPoints to make:

24 Subject Recruitment Programs Research Subject PaymentsPayment amount & schedule must be approved by IRBPayment amount should be reasonable – not coercivePayment schedule should accrue - not contingent on study completionPoints to make: